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Guidance for Writing Case Reports in Addiction Medicine

Oldfield, Benjamin J. MD, MHS; Saitz, Richard MD, MPH

Departments of Medicine and Pediatrics, Yale School of Medicine, New Haven, CT (BJO); Fair Haven Community Health Care, New Haven, CT (BJO); Clinical Addiction Research and Education (CARE) Unit, Section of General Internal, Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical, Boston, MA (RS); Department of Community Health Sciences, Boston University School of Public Health, Boston, MA (RS).

Send correspondence to Benjamin J. Oldfield, MD, MHS, Yale University School of Medicine, 374 Grand Avenue, New Haven, CT 06513. E-mail: [email protected]

Received 20 December, 2019

Accepted 20 December, 2019

The authors report no conflicts of interest.

Methodologically sound interventional and observational studies contribute to knowledge of prognosis, efficacy, effectiveness, and risk. Evidence pyramids place the highest value on systematic reviews and meta-analyses of such studies. 1 These studies do provide generalizable results in populations that can be applied to individuals. But they do not reflect the richness and complexity of individual patient experiences or cases in their contexts. Case reports, although they cannot provide conclusive evidence for efficacy or risk, can provide valuable information of a different type that can impact medicine across several domains.

Case reports:

• (1) can foster clinical reasoning,
• (2) are feasible scholarship for many,
• (3) can serve as an alert to hazards,
• (4) can signal new clinical and service delivery practices, and
• (5) inform health policy.

In medical education, grappling with real cases is a long-lasting way to foster clinical reasoning among trainees in accordance with adult learning theory, 2 so cases often form the bases of grand rounds presentations and standardized test questions. Case reports also are considered a form of practical scholarship for those in training and clinical practice who have frequent occasions to make direct clinical observations, and opportunities for their publication have grown exponentially in recent years. 3 These scholarly reports can alert clinicians and public health agencies to health hazards beyond the reach of clinical trials—eg, vaping and lung injury 4 or the harms of synthetic cannabinoids 5 —and to signals of possibly efficacious new practices that should be tested in more rigorously designed studies. 6,7 They can serve as stimuli for clinical and systems improvement by highlighting challenges and pitfalls in current practice. 8 In health policy, cases capture the minds of voters and lawmakers, informing the allocation of resources based on a combination of facts and the emotional tug of storytelling. Consider Matthew Casey Wethington, who died in 2002 from a heroin overdose at the age of 23, whose story—and the advocacy of his parents—led to Casey's Law in Kentucky that supports involuntary treatment of people with substance use disorders. 9 It is no surprise, then, that cases can play a particularly important role in teaching, studying, generating new knowledge, and advocating for change in addiction medicine, a field whose context is rapidly evolving.

Our experiences editing case report submissions to the Journal of Addiction Medicine have reaffirmed to us the important contributions of case reports to the field of addiction medicine and have also alerted us to their challenges and hazards. Our purpose in this editorial is to identify 4 potential pitfalls of case reports in addiction medicine, and to offer guidance for authors considering writing and publishing case reports in addiction medicine and related fields.

The first potential pitfall emerges from a relative lack of expertise and established standards in case report writing compared to the writing of other scientific articles, for which norms of accuracy, completion, and transparency of reporting have been compiled. 10 The available reviewers for a journal, as well as its editors, may have less experience with case reports than other types of reports. Instruments to assess rigor in case reports are generally lacking, whereas other research approaches such as randomized trials or cohort studies can be systematically assessed for bias and quality via tools like the Cochrane Risk of Bias Tool 11 and the Newcastle-Ottawa Scale, 12 respectively. Such reporting standards ensure completeness and transparency of published reports and facilitate their systematic aggregation.

The second potential pitfall emerges from the sometimes murky distinction between case reports and human subjects research, particularly in scenarios where a new treatment is tried by one or a few patients. How ought consent be obtained in case reports, and when is ethical review (eg, by an institutional review board [IRB] or ethics committee) required? Consent to be the subject of a published case report and consent to participate in a research study are different processes with different guidelines, and authors of case reports may not clearly identify to exactly what the subject(s) consented.

A third pitfall involves a lack of enough information in the report to reliably make substance use disorder diagnoses, assess change over time, or claim effect of an intervention. Internal validity in case reports depends on the triangulation of multiple forms of data, such as clinical history, physical exam findings, and biochemical testing. 13 Given the care fragmentation experienced by many people with addiction and other comorbid conditions, 14,15 whereby primary care services, addiction services, and the management of other conditions may occur in different institutions, data triangulation can be logistically difficult for authors of case reports just as it is for clinicians. Data triangulation can be further complicated by federal regulations specific to addiction medicine, such as Title 42 of the Code of Federal Regulations Part 2, which controls the release of patient information about treatment for substance use disorders. 16 Furthermore, patients with substance use disorders are subject to overlapping forms of stigma, discrimination, and power relations with health care providers 17 , which may impact their reachability by clinicians seeking to verify or collect additional information for the construction of a case report.

A final pitfall is a structural and stylistic one. Unlike other types of scientific articles, case reports do not have specific aims or hypotheses so readers searching for a “take-home point” may not find one as easily as they might while reading other articles. Therefore, without clear statements of the reason for reporting the case, and efforts towards contextualizing the report in the medical literature, it can be unclear to editors and to readers what is novel about the report and how it should inform readers’ thinking about a clinical or systems problem.

Bearing in mind the unique potential pitfalls and strengths for case reports in addiction medicine, we propose the following ethical, reporting, and writing guidance for those writing and publishing them ( Table 1 ).

1. Obtain consent and state clearly in the report what was obtained (eg, written consent was obtained from the patient to report their case in the medical literature). Accepted standards of consent, such as those supported by the International Committee of Medical Journal Editors (ICMJE), should be adhered to. 18 Consent guidelines specific to case reports, such as those presented by the Committee on Publication Ethics (COPE), can guide writers. 19 While individual journals may vary in their guidance to authors regarding the format in which consent should be obtained, the ICMJE and COPE generally recommend written consent to report the case and that the subjects of the report approve the final manuscript if any potentially identifying information is presented.

Authors of case reports need not consider consent to be a one-off, but an ongoing process that may include multiple points of contact between the writers of the case report and its subject(s). 20 At the least, agreement between subject(s) and author(s) as to the decision to write the report as well as approval of its submission should be documented in the report. More than consent, seeking feedback from patients during manuscript preparation can raise the voices of marginalized persons and help disseminate their perspectives. 21,22 In cases where consent cannot be obtained, reasonable efforts in multiple modalities (such as in-person outreach, phone, internet search, or mail) to obtain consent should be documented in the report. In these situations, the authors should explain their reasoning for not obtaining consent and their efforts to do so, they should minimize identifiable features in the report, and the authors (and editors) should attempt to balance the risk of deductive disclosure with the benefit of the case report to public health and science. For example, an identifiable case report (with associated disclosure risks) with little impactful content should not be published (without consent). An anonymous case that has great value could be published without consent after extraordinary efforts to obtain consent failed.

2. Obtain IRB/ethics committee review if appropriate. Authors should reflect on whether their project constitutes human subjects research, and if it may, ethics review by an IRB should be performed and documented in the report. While consent to report a case and consent to participate in research are not the same, the former is always needed for case reports. The latter is needed when there has been human subjects research that requires consent. IRB review is required when the activity is human subjects research, whose definition is widely accepted to include any research involving a living individual about whom data (including private information) or biospecimens are obtained systematically for research purposes to generate new, generalizable knowledge. 23 Therefore, a trial of a new treatment in a single patient with such intent would require review by an IRB. However, a report of a clinical case, in which no information was collected solely for research purposes but was instead done so for clinical care, and no new therapy was trialed, would not. When more than one patient is the focus of the report (which thus constitutes a case series), IRB review is more strongly encouraged. Several major research institutions have concluded that a case series involving greater than three patients ought to undergo IRB review because they are more likely to meet the definition of research as a systematic investigation. 23

For the sole benefit of a patient, clinicians sometimes try new treatments. Such cases might be reported retrospectively as case reports if the initial intent did not include systematic evaluation to generate generalizable knowledge. However, to avoid any confusion regarding whether a new treatment is research or not, we strongly encourage IRB review and approval of any new treatments delivered whose results might be reported with the intent to generalize the findings in a case report. Such new treatments for clinical purposes may also come under Food and Drug Administration (FDA) “single patient expanded access” or “emergency use” regulations for which there are specific IRB and FDA procedures. 24 When drugs are used off-label or with novel dosing strategies in a patient for whom clinicians prospectively decide to collect and report outcomes, these clinicians should consult the FDA's guidelines regarding whether an investigational new drug application (IND) is warranted. 25

3. Triangulate data from multiple sources to minimize threats to internal validity. 26 For example, substance use can be documented by history as well as by body fluid testing, and substance use disorders and their severity can be diagnosed based on criteria established by the Diagnostic and Statistical Manual, 5th revision. 27 Authors should also state how they assessed for diagnostic criteria, for example, via checklists or other instruments, structured interview, and/or a clinical examination. Case reports in addiction medicine that do not include laboratory testing of substances often have limited value.

4. Characterize the relationship between author(s) and subject(s) to clarify potential bias and allow readers to interpret power relationships between writers and subjects. 26 Who solicited historical information, and who obtained informed consent from the patient and at which time periods during the unfolding of the case should be clear to readers so they may determine if internal validity is threatened by bias related to social desirability or coercion.

5. Use reporting standards and structure the report. Cite the standard(s) to which the report adheres. We suggest using internationally accepted reporting standards for case reports. 28 Corresponding checklists ought to be made available to editors on request.

Case reports should have an introduction, the report itself, and a discussion of the case's implications. Introductions to case reports can offer up-to-date, concise reviews of the literature that educates readers about the topic and justifies the need for sharing the case. The justification may address the novelty or uniqueness of the case (eg, a rare disease or rare presentation) or its relationship to a contemporary phenomenon (eg, a success or failure of a feature of a care system, or demonstration of how to apply evidence from a clinical trial). After the case is presented, a discussion should follow that integrates the case in the larger context of what is known on the topic. If hypotheses are generated by the case, they may represent opportunities for future research and these should be stated. In stating a “take-home point,” authors should avoid drawing firm conclusions regarding efficacy or harm given the methodological limitations of the case report. Limitations in drawing conclusions and threats to internal validity should be stated clearly for readers. Strengths should also be noted (eg, the use of biological fluid testing). The discussion section may also include a perspective from the patient(s).

6. Use non-stigmatizing, person-centered language so that the case report may reduce, and not perpetuate, the stigma embodied in certain outdated terms (eg, addict, abuse) that can influence providers’ attitudes and behaviors. 29 Authors are encouraged to reference the statement made by the International Society of Addiction Journal Editors that refers to the destigmatization of language surrounding addiction. 30

William Osler, a foundational figure in clinical practice and medical education, is credited with many famous pearls, including “the good physician treats the disease; the great physician treats the patient who has the disease.” Case reports shift our gaze from the disease to the patient, and in so doing, can help identify novel disease presentations, successes and failures of health systems, and share the experiences of vulnerable patients. As the field of addiction medicine—as well as its legal, cultural, and policy milieu—evolve, case reports represent an opportunity to inform clinical practice, research, and policy. We hope that those who study and treat patients with substance use disorders will take advantage of this form of inquiry and dissemination of knowledge and, in so doing, will encourage readers to take more thoughtful and person-centered approaches to addiction medicine and related fields.

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Report Writing on Drug Addiction [4 Examples With PDF]

In this article, I’ll show you how to write a newspaper report on Drug Addiction. So without further ado, let’s get started.

Drug Addiction in youth

By: Scarlett Ash

November 22, 2020; New Delhi: Drug Addiction is increasing in a geometric pattern on a daily basis. More and more are falling prey to this madness, starting from school students to college students. Reports of new cases are recorded each day. Everybody thinks alcohol is not a drug but that is a misconception. Giving awareness classes can be useful.

Parents should talk to their children for a minimum of one hour so as to understand what is going on in their schools or colleges. Neglecting your children may result in depression which eventually leads to consumption of drugs.

This becomes a practice very fast and grows into addiction. This might even lead them to a stage where they cannot live without these drugs. There are various stages of addiction. This might lead to a drop in performance at school or college.

Actually, addiction is a condition that affects our brain which is manifested by the use of compulsive substances neglecting future consequences. This actually begins with the consumption of drugs in small amounts but over time they build up a tolerance, due to which they need to consume larger amounts for effects.

Drug Addiction In College Students

Reported By: Royce Adams

May 22, 2018; Kerala: The rising number of college students being arrested for drug cases are creating panic among parents. The main reasons for their addiction might be their feelings of unwantedness. How do the students get drugs? That is another side of the picture. There are literally people outside and inside colleges that actually sell it to them.

They might unexpectedly fall into their traps. Some of them want to know how it feels taking a drug. Curiosity is what leads the majority of students into their traps. Once trapped it’s almost impossible to escape. Then you are in the business in spite of your unwillingness.

Some escape, others lose the meaning of life and end up committing suicides. Yet there are few, who escape from this trap. They help others who have fallen into addiction. Addiction is something that happens over a period of time. It doesn’t happen instantaneously. 

Most students fall prey to this unknowingly. Drugs are mixed with drinks during parties where they unknowingly start the usage. Later knowingly or unknowingly they start becoming addicted to such an extent that they can’t pass a day without it.

Increasing Drug Usage

Reported By: Elizabeth Ann, TOI

June 12, 2020; Bombay: The rapid rise in the number of drug cases has spread unusual anxiety among every family. One of the main reasons for the increase in the number of cases is limitless freedom given to the present-day youth.

They are given too many allowances that they don’t know how to spend. Parents have no concern about how or where their children are or what they are doing with their allowances. Parents are least bothered about what their children are doing due to their workloads, leading their teenage children to exotic parties as they have never been before.

Since teenage is an age where you wanna do the impossible and try out new things to show off you slowly start showing off by taking a little bit of the drugs to show others that you can handle it. This creates an immense pleasure and slowly you become addicted.

Others want to know what pleasure you get from using drugs and try them out. Slowly they wanna feel the same way every now and then. That is where you start becoming an addict. They come to a point where they cannot live without these.

Rapid Growth of Drug Usage

By: Sarah Abraham

January 5, 2021; Karnataka: Day by day the number of people using drugs is increasing without limit. Even though the authorities are trying to find how they are able to distribute drugs undercover. Measures are taken to reduce the number of cases.

Necessary precautions are being taken and webinars and talks are being held so that one may understand the impact of the usage of drugs without supervision and also the side effects of the overdose. Overdose may even lead to paralysis or death. Undercover officers are being appointed in every nook and corner of every city.

They are present at every party so as to find out how it creeps into the lifestyle of a person. The findings were unbelievable. They found out that drugs were mixed in their drinks without their knowledge and slowly when the kick sets in, they want more of it.

This is because the drugs mixed in their drinks makes them forget where they are and for a moment they feel they are free from their responsibilities and burdens, that is, a moment of escape into a world they wish, a moment where they can forget everything and enjoy the present moment, thus leading to addiction.

There you have it: Report Writing on Drug Addiction.

I hope you find this article helpful, do let me know if you have any other topic ideas that you want me to cover by leaving a quick comment below this article.

Report Writing: Drug Addiction

A couple of examples to help with your report writing on drug addiction.

Table of Contents

Drug addiction is a chronic disease that affects millions of people worldwide. It is a complex and multifaceted issue that not only impacts the individual but also has a significant impact on society as a whole. In this essay, we will explore the physical, psychological, and social and economic effects of drug addiction on both the individual and society.

Drug addiction can have severe physical effects on the body. It can damage vital organs such as the liver, heart, and lungs, leading to chronic illnesses such as hepatitis, heart disease, and lung cancer. Drug abuse can also weaken the immune system, making the individual more susceptible to infections and diseases. Additionally, long-term drug use can cause neurological damage, resulting in memory loss, impaired judgment, and impaired motor skills.

Drug addiction can have severe psychological effects on the individual. It can lead to depression, anxiety, and mood swings. It can also cause psychosis, delusions, and hallucinations, leading to a loss of touch with reality. Long-term drug use can also cause changes in the brain’s chemistry, leading to addiction and cravings that can be challenging to overcome.

In conclusion, drug addiction is a complex issue that requires a multifaceted approach to address. It has severe physical, psychological, and social and economic effects on both the individual and society. It is crucial to provide support and resources to those struggling with drug addiction to help them overcome their addiction and lead a healthy and fulfilling life. Additionally, education and awareness campaigns can help prevent drug addiction and reduce its impact on society.

Drug addiction can cause severe damage to the body, leading to various health problems. Long-term drug use can damage the liver, heart, and other vital organs. It can also weaken the immune system, making individuals more susceptible to infections and diseases. Furthermore, drug addiction can cause respiratory problems, seizures, and strokes, leading to long-term disabilities.

The social consequences of drug addiction, such as strained relationships, financial difficulties, and legal issues.

Drug addiction is a growing problem in today’s society. It not only affects the individual who is addicted but also has negative consequences for those around them. Drug addiction is a complex issue that involves physical, psychological, and social factors. In this essay, we will explore the physical, psychological, and social effects of drug addiction.

Drug addiction has social consequences for both the individual and society. It can lead to financial problems, loss of employment, and legal issues. The use of drugs can also cause strain on relationships with family and friends, leading to social isolation. Furthermore, drug addiction has a negative impact on society, including increased crime rates, healthcare costs, and decreased productivity. It also has a ripple effect on the community, affecting the quality of life for all individuals.

In conclusion, drug addiction is a complex issue that has physical, psychological, and social consequences. It not only affects the individual who is addicted but also has negative consequences for those around them. It is essential to understand the impact of drug addiction and work towards prevention and treatment to improve the lives of those affected.

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How to write a patient case report

• Article contents
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Henry Cohen, How to write a patient case report, American Journal of Health-System Pharmacy , Volume 63, Issue 19, 1 October 2006, Pages 1888–1892, https://doi.org/10.2146/ajhp060182

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Purpose. Guidelines for writing patient case reports, with a focus on medication-related reports, are provided.

Summary. The format of a patient case report encompasses the following five sections: an abstract, an introduction and objective that contain a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, a summary of the case, and a conclusion. The abstract of a patient case report should succinctly include the four sections of the main text of the report. The introduction section should provide the subject, purpose, and merit of the case report. It must explain why the case report is novel or merits review, and it should include a comprehensive literature review that corroborates the author’s claims. The case presentation section should describe the case in chronological order and in enough detail for the reader to establish his or her own conclusions about the case’s validity. The discussion section is the most important section of the case report. It ought to evaluate the patient case for accuracy, validity, and uniqueness; compare and contrast the case report with the published literature; derive new knowledge; summarize the essential features of the report; and draw recommendations. The conclusion section should be brief and provide a conclusion with evidence-based recommendations and applicability to practice.

Conclusion. Patient case reports are valuable resources of new and unusual information that may lead to vital research.

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• Pharmaceutical Research

Medical Writing in Drug Development: A Practical Guide for Pharmaceutical Research

• August 2020
• ISBN: 9781315870014

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DSI has reviewed many pharmaceutical development reports varying from hundreds of pages to an outline of conclusions fixed to stacks of data. When it comes to putting a regulatory filing together, the latter can make the process challenging.

It has become evident that recording development data and decisions from the beginning in a living document is good practice and evaluating whether the information gathered so far is assisting development aims. It serves as a point of reference for what has been finished and what has yet to be done.

Image Credit: DSI, a PLG Company

Although a development report should ideally be near to a complete state at the time of filing, this is not a complete necessity, explains Kyriakos Michailaros, the Head of Drug Product Services at DSI, a ProductLife Group company.

Better known as Q, Kyriakos states that the development report is designed to tell the background of the drug’s development. It must identify the background science, initial goals, data, experiments and anything that directs the development of the process and establishes the final manufacturing and formulation process.

Start with a plan

All development schedules must begin with a plan. Near the beginning of a project, companies should write a Quality Target Pharmaceutical Profile (QTPP) that outlines what the product is designed to treat, dosing, administration and other appropriate characteristics.

A Gantt chart presents the timeline and milestones to achieve this from early stage and possibly through to filing, Q explains.

Some of the milestones along that journey involve finalizing the formulation, excipient compatibility, phase two, optimization, process development and possibly the end of phase three.

At those points, it’s important to have a report or a risk assessment documenting the data collected and the conclusions and decisions made based on that data for the development program. Better yet, a characterization report outlines your critical process parameters and demonstrates that you can consistently make the product. ” Kyriakos Michailaros, Head of Drug Product Services, DSI, a ProductLife Group Company.

A widespread challenge is that data tends to be in different reports until the filing stage. This is because turnover can be common in the development team and development programs progress over the years.

Creating an up-to-date living document can solve the issue of managing the various stages of the process and recording the complete history of the program.

“ Having your development data and conclusions automatically downloaded to a common document means you have all the critical information that you’re basing your development program on in one place, ” Q explains.

“ So, if you’re having a meeting with the FDA or planning a filing, you know where to find all the relevant information. ”

It is also important to record data that was not utilized in the development because every effective program performs risk assessments throughout the journey to show that the main challenges have been solved.

Piecing it all together

Q and his team as CMC consultants usually note that the development story requires a jumble of organized and often disorganized assessments, data summaries, reports which may or may not be finished, and batch records to be pieced together.

The main advantage of a working development document is to keep the information in one location, where there is a shared understanding of where data is stored.

This eliminates confusion and saves time for the members of a development program. It makes it simple to see the information that has formed the basis of decisions and if there are any gaps.

Creating a complete report of development work so far helps possible buyers with the process of due diligence, even if a business chooses to only take a product to the IND stage before looking for a buyer.

An alternative and effective method would be to create a working document repository with a file structure that can be followed in order to build a report.

Q states, “ I think it’s actually more important in a situation like that, where you don’t want to take a project all the way to completion, to have a working document because you’re not then scrambling to get something together that’s coherent if and when you enter talks with a potential buyer. ”

Addressing the gaps

It is crucial to establish what the gaps are in a business development program as it becomes closer to milestones. This is where CMC experts like Q are called in to offer a gap analysis.

Q states that when performing a gap analysis, “ The first thing I would check is that a company has the appropriate stability information . Is the stability on the finalized packaging configuration or formulation or process in line with expiry data? It takes time to acquire stability data, so fixing this issue will take some time. ”

Further areas to evaluate are whether the process control parameters have been correctly measured and if they are suitable for the drug product and the procedures that are utilized to manufacture it.

There are several types of drug products, and it is essential to take an approach that is tailored to the product when investigating. It is important to understand which regulations are relevant and to know the explanation behind the choices that are made.

“ At the minimum, you need to check the boxes, ” Q explains. “ You need to have the particular issues that are known for the type of formulation, for the type of drug product, for the type of packaging configuration, pretty well covered because they’ll be scrutinized. ”

Start early, stay up to date

Q and his team, as drug product subject matter experts, have worked on several reports where the source documents were incomplete and disorganized. Not only is it time-consuming to solve this, but it also leads them to question whether certain development tasks have been recorded in full.

“ It’s never too early to start your development report to have the story of the development complete and summarized by the time you’re making an NDA submission, ” Q explains.

“ With information easily available, it becomes simpler to put forward arguments to the reviewers, present explanations and justifications for certain data, and tackle difficult issues head-on, rather than wait for reviewers to notice the problematic data during the review, ” states the principal and chief regulatory scientist Ed Narke from DSI.

Acknowledgments

Produced from materials originally authored by Meranda Parascandola from Design Space InPharmatics .

About DS InPharmatics 

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Narrative writing: Effective ways and best practices

Samir d. ledade.

Department of Medical Writing, Tata Consultancy Services, Mumbai, Maharashtra, India

Shishir N. Jain

Ankit a. darji, vinodkumar h. gupta.

A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier. Narratives aid in the evaluation of the safety profile of the investigational drug under study. To deliver high-quality narratives within the specified timeframe to the sponsor can be achieved by standardizing processes, increasing efficiency, optimizing working capacity, implementing automation, and reducing cost. This paper focuses on effective ways to design narrative writing process and suggested best practices, which enable timely delivery of high-quality narratives to fulfill the regulatory requirement.

INTRODUCTION

Medical writing is a specialized field in clinical research domain, where scientific documents are prepared for regulatory submissions. These documents require adherence to regulatory guidelines in terms of structure, content, and format. Narrative writing is an integral part of medical writing services. The purpose of writing patient narratives is to provide a concise summary of identified/specific adverse events (AEs) occurring in a patient to conclude causal relationship between the investigational drug and AE. These narratives are submitted along with the clinical study report (CSR). The approximate length of narrative may vary from one to four pages depending on the number of AEs, and data availability for a particular patient/event. In a CSR, the number of narratives could be as huge as 1000, depending on the phase of the trial. Thus, the sponsor may choose to outsource narrative writing activity to effectively manage cost, time, quality, and in turn overall project management. Considering current trends, this article focuses on providing guidance to a medical writer for better understanding of the process, how to drive the narrative writing process (NWP) effectively, regulatory norms, challenges, mitigation strategies, and trends toward automation of narratives.

Patient narrative is a summary of AEs occurring in a clinical trial patient/subject. It is generally written for the following criteria: Death, serious AE (SAE), event(s) of special interest, AE leading to study drug/trial discontinuation, and adjudication event(s). It should be written in a structured way with clear, concise, and logical flow of information. It should follow succinct style and presentation and should provide a medical and scientific context in terms of the event(s) for which it is being written. The logical flow to describe event(s) in a patient narrative is as described below:

• Clinical course of the events, with an indication of timing of event corresponding to study drug administration
• Nature, intensity/severity, and outcome of the event
• Relevant laboratory findings
• Treatment administered for the event
• Action taken with respect to the study drug
• Postmortem findings (if applicable)
• Investigator's and sponsor's assessment (if required) on causality.[ 1 ]

In addition, it should also include patient identifier, age, sex, race (height and weight, if relevant), disease being treated (if relevant), prior and concomitant medications, medical history, and active/ongoing medical conditions.

TYPES OF NARRATIVES

The type of narratives depends on whether the trial is ongoing (interim analysis) or completed. For completed studies, if the number of narratives is large (approximately >150–200), narrative writing activity usually starts along with cleaning of database. These are usually referred to as Predatabase lock (DBL) narratives. If the number of narratives is less (<150), narrative writing activity may start along with CSR preparation. If the narratives are written based on pre-DBL data, these narratives will be updated/modified based on post-DBL data which is considered clean and final. Final narratives are submitted with the CSR as an appendix. For studies under interim analysis (ongoing studies), it is advisable to initiate narrative writing activities well before the data cutoff date and per protocol recommendations. In such cases, only the events which occurred before the cutoff date will have the narratives written for. Narratives may be written in text or tabular format depending on the requirement.

Patient and safety (pharmacovigilance) narratives

A patient narrative is written for each patient who experiences at least one of the qualifying events as per the criteria defined and agreed upon with the regulatory authority. Thus, a patient narrative may have more than one qualifying events and is submitted as an appendix to the CSR. However, for spontaneous reporting, a safety narrative is written for each event or a couple of events that occurred together.

DATA SOURCES

Data sources required for drafting patient narratives usually comprise (a) primary data source which includes clinical database (patient profiles in the form of pdf/excel/rtf, or patient listings in the form of pdf/excel/rtf/doc, or case report form) and (b) supplementary data sources such as Argus/the Council for International Organization of Medical Sciences/MedWatch forms/data clarification forms that aid in providing details about the event(s) and its course in the narrative.

THERAPEUTIC AREAS

Patient narratives are written across all therapeutic areas and for all phases of clinical trials (Phase I–IV) depending on the drug under evaluation (molecule and its mechanism of action). Framing the template for the narratives is a critical step that requires extensive knowledge of the relevant therapeutic area.

It is important for a medical writer to have a thorough understanding of the therapeutic area for working on a narrative project, as it helps in having a better understanding of the safety profile of the drug class and its derivatives.

REGULATORY REQUIREMENTS

Patient narratives are submitted to regulatory authorities along with the CSR. They are included either as a text in Section 12.3.2 of the CSR, if the number of narratives is less (6–10), or provided in Section 14.3.3 as an appendix. The narratives can also be appended in the CSR addendum (usually required for legacy studies, if the narratives are not submitted earlier). They may also be submitted as Food and Drug Administration/other health authority response document, if the regulatory authority identifies and requests narratives for any event/s of interest due to safety concerns. Patient narratives are also submitted for Data Safety Monitoring Board review, if there are any safety concerns for the study drug which need evaluation by an independent committee on an ongoing basis.

REGULATORY REVIEW PERSPECTIVE

A medical writer has to keep several factors in mind while drafting a narrative. As the narratives get reviewed by regulatory authorities, it is important for a medical writer to understand their role and expectations while drafting a narrative. Usually, regulatory authorities check the narratives with the following objectives during their review:

• To identify and closely examine AEs/SAEs that require further monitoring[ 2 ]
• To identify and monitor frequency, severity, and seriousness of unexpected AEs
• To identify the factors which affect and predict for the occurrence of adverse drug reactions including patient-related factors such as age, gender, ethnicity, race, target illness, abnormalities of renal or hepatic function, comorbid diseases, genetic characteristics such as metabolic status, environment, and drug-related factors such as dose, plasma concentration, duration of exposure, and concomitant medication[ 2 ]
• To evaluate whether the data are suitable for support of the safety analysis[ 2 ]
• To identify the limitations of the drug on the basis of data[ 2 ]
• To evaluate and analyze drug–drug interaction, if applicable.

NARRATIVE WRITING PROCESS

Narrative writing is a complex process that involves various stakeholders. Figure 1 represents stakeholders involved in NWP. The process begins with template finalization which is a crucial step in the NWP as it avoids subjectivity. It is advisable to write sample narratives for all possible criteria, which usually ranges between three and five narratives; however, this may vary based on the total number of narratives for that study and the team's preference. Finalized sample narratives need to be clean, concise, and appropriate, as they form the basis for drafting further batches. Thus, an agreement with all the stakeholders/reviewers on the content/template of sample narratives is desirable. Finally, the compiled batch of narratives is shared with the respective stakeholders before publishing. For the purpose of audit trail, all versions of the narrative document should be stored in the repository/document management system. Figure 2 represents the generic process for handling any NWP.

Stakeholders involved in narrative writing process

Process steps for handling any narrative writing project

CHALLENGES IN NARRATIVE WRITING PROCESS

Of the several challenges encountered while drafting narratives, the most commonly observed challenges are (a) large number of resources required for any given project, (b) maintaining consistency in the narratives due to multiple resources working on the same project, (c) requirement of quick turnaround time and timely delivery with high quality, (d) not having standardize data sources/patient profiles for most of the programs, (e) different types of data sources, (f) high variability in template finalization before and after sample narratives due to differences in opinion of the reviewers, (g) change in reviewers during the intermediate/later stages of the project, (h) delay in review cycles, and (i) not receiving timely clinical team consensus on the addressed comments and pending queries.

Mitigation strategies/tips

Mitigation strategies/tips for the aforesaid challenges include (a) excellent project management skills for efficient resource utilization, (b) automation of narratives, (c) standardization of data sources/patient profiles throughout the process, (d) finalization of template before starting sample narratives, in consensus with the clinical team, (e) finalization of sample narratives before dispatching future batches, (f) rigorous follow-ups and proactive communication with all the stakeholders (g) letting everyone know the impact of delay on timelines, (h) standardization of the review process, and (i) regular calls with clinical team to address review comments or pending queries.

EFFECTIVE WAYS TO EXECUTE NARRATIVE WRITING PROCESS

Review of data sources.

Before drafting the sample narratives, it is prerequisite to review the data sources (patient profiles or listings) for all the necessary information as per the agreed narrative template/content and protocol requirements. Every data point in the template should be mapped against the patient profile. Missing/discrepant data, if any, should be highlighted on an immediate basis, and its inclusion or deletion in the narrative needs to be justified.

Data validation

Data validation/data quality control (QC) process is of prime importance to all the stakeholders as it helps in generating a high-quality narrative document(s) and is an integral part of the entire project management. Narratives that are generated with the aid of automation tool needs validation of data against the data sources to ensure quality. The lead writer should randomly perform data QC of automated narratives to confirm data accuracy and credibility. Any discrepancies should be fixed immediately, so as to avoid such errors in the future batches.

Quality calibration

Quality calibration is a paramount step to ensure consistency within the narratives in a batch and among the team members so as to meet reviewer(s) expectations. Usually, quality calibration should be performed on a quarterly or biannual basis. It also helps in tracking inter- and intra-variability while performing QC of the document. Quality calibration involves assigning the same narrative for QC to different QCers and to the same QCer at different time points, and checking inter and intra-QCer variability against the master QCed narrative.

AUTOMATION OF NARRATIVES

In the current digital era, revolution in technology has brought modernization in health-care industry to effectively operate the process in an efficient and convenient way that significantly reduces the cost of pharmaceutical organizations. Automation in narrative writing is a current trend that every pharmaceutical industry is adopting to provide quality and consistency within the narratives batch. The tool which helps in creating automated narratives, extracts relevant information for all the identified patients in desired format/template. This tool is very helpful for studies with large volume of narratives (usually >150).

The key features of autogenerated narratives are:

• Consistency in narratives
• High-quality narratives with minimal/no error
• Preformatted and editable narratives generation, which gives flexibility to modify based on the need
• Decrease turnaround time for overall narratives
• Ability to generate graphs and bar diagrams
• Maintain audit trail and version control at each stage.

Medical review

Medical and scientific review of the narratives is a must, even if the narratives are generated with an automation tool. Narratives should make sense from a scientific perspective; hence a thorough medical and scientific review is desirable to conclude event(s) summary.

A medical reviewer possesses in-depth knowledge of the therapeutic area and usually verifies medical plausibility of the event/s, inclusion/exclusion of the content from a scientific perspective, safety data reported in the narrative, and flow and alignment of contents according to the applicable regulatory requirements.

PROJECT MANAGEMENT

Project management plays a vital role in effectively managing the NWP, considering that the quality and timely submission is paramount to success. Tracking the total number of narratives, name of resources, and other activities are critical in projects involving a large number of patient narratives. MS Excel can be used as a tracking tool for managing large volume of narratives and is particularly useful if all stakeholders are able to adapt each other's processes. This may not be applicable in instances, where it records confidential information such as time spent per narrative for budgetary purposes.[ 3 ] Effective project management mainly involves the following activities:

Resource management

Managing resources during narrative writing projects is critical and usually depends on submission timelines. Adequate allocation of resources in each project also depends on duration of the project, total number of narratives, availability of resources, and their therapeutic area expertise.

Narrative tracking sheet

The narrative tracking sheet is a tool which includes list of patients requiring narratives and their criteria (death, SAE, AE leading to study drug discontinuation, and event of special interest). This tool may be used to capture few other details such as author, reviewer, and dates.

Resource utilization tracker

Resource utilization tracker lists down all the ongoing studies and percent utilization and free capacity of resource(s) in each project.

Master tracker

This tracker may include all the ongoing, completed, and planned studies with detailed description of each.

Quality dashboard

It is very important to maintain quality of each narrative and to track the quality in a quantitative manner; quality tracker should be in place. Generally, quality scoring sheet is used to calculate major and minor errors of narratives to meet quality parameters as defined by customer. Study wise and writer wise error trend analysis may be performed with the help of this tracker.

A FEW TIPS FOR NARRATIVE WRITING

• Always use hard space and hard hyphens for days, dates, and laboratory values to avoid splitting on next page or next line except at the beginning of sentence (hard hyphen: ctrl + shift + hyphen; hard space: ctrl + shift + space)
• Be consistent while using patient or subject throughout the narrative, as per agreement with clinical team
• Tagging the narrative template against the information available in data sources which helps the QCer/reviewer to trace the information easily
• Always use generic names for concomitant medications or AE treatment medications. Exception: For combination drugs, generic drug name should be provided along with trade name in bracket, for example, lisinopril-hydrochlorothiazide (Zestoretic)
• Always use preferred terms (PT) for the event and medical history/ongoing condition. The verbatim term should only be used if there are same PTs for two different conditions (e.g., PT: pain in extremity should be reported as pain in hands or pain in legs)
• Self QC by the author is very important step forFirst Time Right approach.

This article focuses on ways to overcome challenges encountered during the NWP, and the best practices to ensure high quality and timely submission of narrative documents to the regulatory authorities. Automation in narrative writing is an emerging approach, and most of the pharmaceutical companies are adapting it to be resource, cost, and time efficient.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

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Chapter 9:  Professional Writing

Patrick M. Malone; Meghan J. Malone

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State reasons both for and against writing professionally.

Describe the various steps of professional writing.

Identify the order for authors in a professional paper.

Describe the importance of knowing the audience.

Describe various writing styles and their differences.

Explain where to find a publication’s requirements for submission.

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Essentially any time a professional takes pen, pencil, word processor, or any other writing implement in hand to fulfill professional duties, it is considered professional writing.

When writing, it is best to keep things as simple and direct as possible.

With the probable exception of policy and procedure documents, the two most important paragraphs in any document are the first and last.

If the information is taken from a particular source, even if it is reworded, the original author should be given credit via footnotes or endnotes.

In many cases, revision of a document will be necessary.

Instead of concentrating on the technology, it is best to concentrate on the message.

Professional writing is a skill necessary for every health professional.

A common thought when considering the topic of professional writing is, “That doesn’t apply to me, I’m not writing for a journal.” But professional writing is certainly not limited to journal articles or books. It includes writing evaluations of medications for consideration on a hospital formulary, preparing written policies and procedures for the preparation of an intravenous admixture, reporting the results of the latest sales to the home office, preparing a written evaluation of a technician or clerk, writing in a chart, writing a term paper for a class, preparing slides or posters for a presentation, writing a letter of recommendation, 1 and many other things. ❶ Essentially any time a professional takes pen, pencil, word processor, or any other writing implement in hand to fulfill professional duties, it is considered professional writing. When writing, although the format changes, the general principles remain the same. So whether the objective is to write the ultimate book on the practice of pharmacy or to type a label, a pharmacist must know how to write professionally.

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How to Write Realistically About Drug Use in Your Novel

Today’s post is excerpted from The Grim Reader: A Pharmacist’s Guide to Putting Your Characters in Peril (Red Lightning Books, 2024, used with permission) by Miffie Seideman .

Writers have asked how they can realistically describe a drug they’ve never personally used. How can they accurately portray a character’s actions or symptoms?

Know your history

Building a credible scene requires researching some historical facts, including:

• Was the drug discovered yet? A scene using insulin set in 1820 is problematic since this treatment wasn’t discovered until the 1900s. Fentanyl shouldn’t be used in a 1930s scene since it wasn’t available for use until the 1960s—opium or morphine would be more accurate choices.
• Was the method to take the drug invented yet? Since insulin must be given as a shot, that scene is even less authentic as the hypodermic needle wasn’t invented until the mid-1800s. Older historical fiction could involve the use of poultices and mustard packs, while skin drug patches (transdermal patches) are only appropriate in more modern scenes.

You also need to consider what drug trends existed in the time period of your story. Medical knowledge changes over time and with it the drugs prescribed. This, in turn, impacts the type of prescription drugs diverted into street supplies or available in home medicine cabinets.

Here’s a sample scene:

He picked up the empty glass vial next to her lifeless body. Chloral hydrate! He’d been a fool to leave it where she could find it.

Is this author’s sedative choice realistic? It depends on what year the scene takes place. Popular sedatives have changed significantly over the decades. In the late 1800s, chloral hydrate was popularly used to treat anxiety and insomnia. It was replaced by bromides, which were also unfortunately used to create the “bromide sleep” to sedate patients in asylums. By the 1920s, awareness that bromides caused prolonged hallucinations led doctors to prescribe barbiturates like phenobarbital (barbital) instead. So, it was no accident that Agatha Christie chose to weave barbital into the plot of Murder on the Orient Express . Once the medical profession realized the growing trend of barbiturate addiction, benzodiazepines (“benzos”) became the new alternative. Surprisingly, despite safety concerns, it wasn’t until the early 2000s that chloral hydrate was finally removed from the US market.

Based on these prescribing changes over time, how would you revise the sample scene to take place in the 1940s? In 2000?

Sample scene, setting 2020:

He quietly opened her medicine cabinet, fumbling through bottles, until his fingers landed on the one labeled “Vicodin.”

Over the last decade, the growing opioid crisis has caused concerns about overprescribing and addiction. But in the early 2000s, poorly treated pain created a national push for better pain control, resulting in increased prescribing of opioid drugs such as oxycodone, hydrocodone (Vicodin), and Percocet. Eventually, this led to an oversupply of opioids, excess stores in medicine cabinets, and increased street supplies.

Then, with addiction and overdoses escalating rapidly, additional prescribing restrictions enacted in the US reduced drug availability. The unintended consequence of this was an increase in the black market demand for opioids, which escalated illicit drug smuggling into the US. This influx of opioids has included illicit fentanyl, both in bulk and laced into street drugs such as heroin and counterfeit pain pills. The culmination of these events has resulted in the current fentanyl overdose epidemic.

Due to these rapid social changes in a span of only twenty years, an opioid scene set in 2020 will look very different than one set in 2000.

So, is the scene above appropriate? If the character’s grandmother held onto leftover hydrocodone (Vicodin) after her last surgery a couple of years ago, then yes. Many people, especially the elderly, squirrel away leftover tablets instead of tossing them into the garbage. Some patients hoard pills, afraid they won’t be prescribed enough the next time they’re in pain. But if the character’s grandmother is depicted as having been given the pills after a recent surgery, then no. Opiate prescribing in the US has been extremely restricted during the last several years. Few opioids are prescribed after surgery and when they are, the number of tablets is usually enough for only a few days of treatment. In this case, it would be more realistic to have the character not find the pills he wants and resort to buying some from his friend at school. And where would his friend have gotten the pills? He probably bought them from a stranger at a party.

Study drug abuse trends

Different countries, and different locations within countries, have varying trends of drug use and abuse over time. Factors affecting these differences are complex, but include laws, local cultures, drug availability, drug costs, and proximity to country borders. A drug-related scene in a town along the US-Mexico border will look quite different than one set in a Midwest farming town. The resources page at the Drug Enforcement Administration (DEA) website contains a wealth of information regarding location-based trends in drug abuse and even maps of the locations where clandestine labs have been found. The National Drug Threat Assessment, published regularly on the site, details national data related to illicit drugs. For international information, a great resource is the United Nations Office on Drugs and Crime website.

Research slang and look for “trip reports”

How your character talks about drugs and the related paraphernalia is just as important to sounding authentic as what the character does with them. A well-written scene using drug jargon can immerse readers in the setting, even if they don’t know what the exact terms mean. A great example of this can be found in Good Girls (Season 1, Episode 6) when Boomer pressures Darren into selling him drugs. Darren’s response—the litany of drugs he has available to sell, including everything from “Addys” to “fat bags of herb”—is both authentic and funny.

Drug jargon not only changes over time but also with geographic location, age, socioeconomic status, and a host of other factors. Hundreds of street names and a wide variety of related slang exist for various drugs. But applying slang to your scene will require additional research to identify the terms that will sound the most authentic in your story. For example, while doobie and vape are slang terms used for marijuana, having your 2020s high schooler talk about “takin’ a hit off a doobie” would be as out of place as having a 1960s hippie invite someone to “vape some dank weed.” And jargon like dubsack and trippin’ balls should be used in the right context.

Online videos posted by recovered addicts or current users offer a well-rounded sense of how to use such jargon realistically. Using the search words trip report with the name of a drug can be a starting place. For example, a search for DXM , third plateau , and trip report will result in numerous videos of users that were filmed during their DXM trips, offering profound insight for writing a scene. In addition, a few social influencers have posted videos documenting their journey through drug addiction, recovery, and sometimes even relapse.

Consider socioeconomic status

What’s your character’s income? What are the economics of the setting? Crack is a credible choice in a plot involving a low-income character because it’s a relatively cheap drug, while a cheese platter spiked with ecstasy is more appropriate in a high-society women’s brunch scene. Is your character a penniless alcoholic? Instead of passing out after chugging a fifth of Tanqueray gin, the medical responders should find him near death from drinking cheap isopropyl (rubbing) alcohol.

The market cost of drugs has an impact on drug trends. For example, in about 2013 Arizona high school students switched from abusing expensive oxycodone pills to cheaper and more available heroin. But an influx of illicit pills from Mexico has driven oxycodone prices down, making it the preferred choice again. Many of these pills, however, are counterfeit and tainted with potentially lethal doses of fentanyl. Now, an upsurge of fentanyl overdoses and deaths are being reported in those same high schools.

How is the drug usually used?

Avoid the temptation to improvise ways to get the drug into your character just to fit a scene. Most drugs given the wrong way won’t work as planned. If your villain spikes a drink with insulin to kill an adversary, he’ll be sorely disappointed when his victim lives. Insulin must be injected or, in some cases, inhaled, to avoid destruction during digestion.

Learn how fast a character should show symptoms

Avoid writing instant drug effects. They are almost always unrealistic. Instead, build page-turning tension using the actual time it takes for drugs to cause harrowing symptoms. Despite what movies would have you believe, a chloroform-soaked rag won’t make a character instantly pass out, and the effects will wear off quickly after the rag is removed. Even injecting drugs rarely works instantly. For example, a villain attempting to kill with an overdose of insulin shouldn’t see the victim immediately fall to the ground. Insulin takes time to work, initially dropping the person’s blood sugar, leaving his brain foggy, his vision blurry and making him shaky. As his blood sugar drops dangerously low, he can suffer a seizure and lose consciousness. Now your character is on the way to dying.

Use the reader’s own knowledge and need for suspense to your advantage. Did your character swallow a handful of pills? Since many people know it takes several minutes for pills to have an effect, you can let your readers build their own anticipation, waiting for the inevitable, while you slowly develop the scene tension.

Need to hasten a character’s demise? Write the scene using a drug that can be injected into a vein (IV) or inhaled, which generally works faster than a shot into muscle (IM) or swallowed pills. Reserve plots using a skin patch for slow-moving scenes since it takes time for drugs to absorb and cause symptoms. High or lethal doses can rapidly create dangers for your character. But, for any of these methods, symptoms should still appear in a cascade, not all at once. For example, a rapid injection of a high fentanyl dose can suddenly cause chest muscles to become rigid, making it hard or impossible to breathe. Then, with no oxygen, several other symptoms can evolve—such as blue lips, seizures, a slowing heartbeat, and death—over several minutes (or pages). The character shouldn’t die instantly, even with this potent drug.

And keep in mind that not all overdoses are lethal. Depending on the drug, your character may suffer serious symptoms but realistically survive. This fact offers a world of harrowing conflicts that can make your character strong enough to ultimately tackle his inner demons.

A note of caution when using brand names

An abundance of caution should be used when deciding to use the brand name of a drug in your story. Brand names can be acceptable, but using language that tarnishes, defames, or falsely depicts a product as dangerous can bring litigation. Authors can circumvent these concerns by avoiding the use of brand names entirely. It’s often not even necessary to specifically mention a drug name to develop a scene. Instead of mentioning the brand OxyContin, build tension as the character opens the leftover bottle of pain pills. Instead of Adderall, a stressed college student studying for finals can reach for his “study buddies” bought in a previous scene. Simply describing what the medicine does can be effective, evoking the reader’s memory of similar experiences. If you want to be completely fictional, invent your own brand name, but try to stay within the symptoms expected from that kind of drug. Suzanne Collins blended several of these concepts well in The Hunger Games series. The sweet syrup that calmed Gale’s pain and was extremely addictive was reminiscent of morphine. If you do choose to use a real brand name, consider getting a legal consult to verify that you haven’t crossed the boundaries of acceptable use.

Additional resources

There’s a wealth of drug information available. A few resources to consider include:

• FDA (Food and Drug Administration) and DEA online databases and drug resources, which provide information on changing trends in various geographic locations as well as updates on the legal status of various drugs.
• Social networking groups focusing on related specialty writing topics, such as trauma or emergency medicine, can be a wealth of information.
• Newspaper articles and medical journals are great places to find real cases.
• Local medical professionals, police, and medical examiners can provide insight and realistic ideas.
• The US national poison center is an often-forgotten resource that collects data from fifty-five poison centers throughout the US. It provides free information to the public on poisonings, drug exposure, chemicals, poisonous plants, and venoms. It’s a wealth of information on trends in drug abuse, overdoses, and poisonings based on age groups and geographic locations. The poison center is also available to guide the general public during poisoning emergencies, such as the frantic parents of a toddler found chewing on iron tablets next to an empty vial.

If you found this post helpful, be sure to pick up a copy of The Grim Reader .

Dr. Miffie Seideman, Pharm.D. worked as a newborn ICU pharmacist for over 25 years, lectured on medication errors and drug safety, and led medication safety teams. As an avid triathlete, she also spends long training rides developing her new gritty YA fantasy, mixing demons, dragons, and betrayal. She lives in Phoenix, Arizona.

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This is actually so relevante necessary! What an awesome idea. I am so glad someone put this together. You watch shows all the time and sit there going “this isn’t realistic” so this book definitely will make authors write about something they probably don’t understand and help them realistically do it!

Hi Kacee! Thanks for dropping by. Those unrealistic shows were definitely a big driving force behind the concept of this book. Good luck with your writing this year!

This is excellent advice! I’ve had to write about drug use in a couple scenes in my books, and I wish I had this advice available to me then.

And you’re absolutely correct about not using brand names in any way the company could object to.

Thanks for a great article!

Hi Dave! I’m glad The Grim Reader will be there to help you going forward. The brand name use has been a question in a number of my writing groups. I thought it was a good chance to clarify the legal risks and save some authors serious trouble. Good luck with writing in 2024!

I love all the plot prompts in this post. Thanks for the Amazon book link as well! I’ll add it to my Kindle.

Hi Jenny! It was so important to me to include the prompts. I love seeing writers get a chance to use the information too develop their own characters and plot twists. I’m glad you loved them. Thanks for dropping by.

I remember a few years ago when you began thinking about this book. I’m so proud of you! Such a brilliant concept and needed book for authors. Getting a copy for my shelf! Brava!

Thank you so much for all your support John! It has been a wonderful adventure for sure. I’m really looking forward to taking the concept to workshops and conferences to give writer’s hands-on experience, also. Good luck with your writing this year!

This is a real treasure! A fantastic and needed resource. The Grim Reader will help a great deal with accuracy in scenes where drugs are used.

Hi Ellen! Thank you so much. I’ve enjoyed writing it. Good luck with your writing.

So happy this book is finally seeing the light of day, Miffie. It’s such a great resource and needs to be on every writer’s shelf!

Thank you, Eldred. Everyone has been wonderfully supportive from the beginning of the concept. I’m really looking forward to The Grim Reader being out there to help writers.

Beyond being an author and seeing the obvious benefits of accuracy, I relate to so much in this article. As chronic pain is an issue for me, I often struggle not to hoard pills from old prescriptions. I think the fear comes not only from not being prescribed what we see as “needed” in the future, but the pain being unbearable while we wait for the doctor appointment to even be prescribed the medication. This obviously would create a small stockpile of expired meds that could be stolen or used by someone from inside or outside of the home. The excerpt is incredibly helpful (and reads 100% accurate – which I suppose is the point). I need to pick up a copy of the full book.

David- your struggle mirrors so much of what patients go through with pain, often leaving dangerous amounts of supplies at home and suffering uncontrolled pain. And while it makes for some great plot twists and character backstories, it’s can have devastating consequences in real life. My heart goes out to you for the struggle. Thank you so much for sharing your insight and comments on The Grim Reader!

Wow, very detailed. I live in Southern Ohio where drugs are the real death dealing pandemic – “Equal opportunity destroyer.” One symptom of all addictions is lying – about everything, all the time. Thus, 1st person reports, AA calls it “drunkalogues” are very suspect. The opposite is usually what really happened. You see this flaw in most (all) film stories about addiction and the person with addiction – cop/lawyer/etc – “with a heart of gold.” Anytime a AA meeting scene shows up in episode one – be prepared for cliches. But, they sell… Also, medically, people are not their diseases. I never use dehumanizing words like addict/junkie/etc. Lazy art. They are people suffering from – largely inherited addictions – not “addicts” (or narcissist’s/etc.). One addiction topic that is rarely written (or talked about) is sex addiction. It is a cultural joke. But, Epstein, etc demonstrates how really harsh that reality is – it usually involves children and violence. A real challenge for any storyteller! Yikes! There are nuances on the whole sex abuse topic that complicated for (anti) social media, eg, most abusers were abused by “friends and family” themselves…etc… My motto for all my work is “Go dark; go deep.” so appreciate the post.

Thank you for sharing your perspective. Addictions are such a complicated topic, with such far reaching implications. And yes, so many first-hand accounts are tainted. Good luck with your writing.

What an informative piece! I’m cringing thinking about a scene I wrote earlier in my writing career where a  chloroform-soaked rag caused a character to instantly pass out. That’s what I get for using movies, novels, and television shows as research. 🙂 I will be picking up your book!

Hi Dina! Thank you. And you aren’t alone in having those dubious sources influence past work. 🙂 But now that you know, your next scenes can be suspenseful page-turners, while your readers wait for that chloroform to take effect. I look forward to reading your stories!

Incredibly helpful resource! Thank you for collecting this information all in one place. Ordering the paperback to add to my reference collection.

A dear friend is a retired ER doc. She’s helped me include accurate details in numerous scenes.

In the ’70s and early ’80s, a family member was a trendsetter, using “crystal,” which he described as high-octane speed. Few people were familiar with it then. Rehab facilities were at a loss how to treat this extreme addiction. Now…well, as you say, times change.

Hi Debbie! I’m so glad you’ve been able to tap into the ER doc. What a valuable resource. And yes! Times do change. Even now, there’s a more potent meth hitting the streets, along with the newest fentanyl versions. Thanks for getting the paperback and good luck with your writing.

Paula Writes

Paula puddephatt – author, writing about substance abuse in your fiction.

Drug addiction and alcoholism are challenging, controversial, and complex to write about, but I personally choose to address both, in my fiction.

I do have personal, although not recent, experience, in the areas of problem drinking and volatile substance abuse – but not of using illegal drugs.

There are many resources that can help with our research online, but definitely, a lack of material dealing specifically with how to write about these issues, in our fiction. I hope that this will change and, even though I can by no means claim to be an expert on substance abuse, I’m going to share what I am able to, at this point in time.

I did touch upon the subject of drug and alcohol abuse, in my post regarding how I address mental health issues, in my fiction . Mental illness and addiction are closely related, so I would suggest reading that post, for further insights.

Now, let’s get into the tips for writing about characters with substance abuse issues.

Just one more quick note first, though – to mention that addiction covers much more than substance abuse. I recognise that addictions to gambling, shopping, and so on, are very real. I simply can’t deal adequately with those, in the context of this one post.

Drug addiction, alcoholism, and binge drinking are also subjects that feature heavily in my WIP, making it natural that I would make it a priority to discuss these matters, here on my blog. 2020 update: The WIP, referred to here, is my novel Distorted Perceptions , which was published this year .

It’s vital to know about the physical effects of any substances your characters are abusing.

That’s the absolute minimum, so start your research there.

Know how the drug alters the personality and behaviour of your character.

If a character is introduced to readers prior to the addiction, contrast and changes will be easier to demonstrate. Early warning signs should be evident.

Know in yourself, at least, how the character was before. It may mean delving into backstory. Was there any trauma, in the character’s past, that contributed to development of the addiction?

There will be some perceived benefits.

What does the drug do for the character? Does it numb physical or/and emotional pain? Ease symptoms of anxiety? Alcohol, for instance, is often used in an attempt to self-medicate, by sufferers of social anxiety.

There will be specific ways, in which the addiction clearly controls the character. Make sure that you show some of these.

How does the person fund their habit?

Any committing of crimes, such as burglaries? Has the addict become a dealer? And, of course, to say that it is not easy to escape those networks, is an understatement. Attempting to do so could place the person, along with loved ones, in very real danger. This would be an obstacle to recovery, even if the character was able to “get clean”.

How have relationships with family members and friends, who are not themselves addicts, been affected?

People, however close, will draw the line somewhere, and most will, ultimately, walk away. So much damage will have been done, possibly over years or decades.  There can come a point, at which the strain is more than the relationship can take.

Usually, an addict will reach a crisis point – rock bottom, basically – and then decide to change.

Is your character able to give up drugs, drink, or both – as applicable? Does the individual subsequently relapse?

Do your research regarding the long-term health implications.

There could be serious, and even fatal, physical health consequences. Equally so with mental health. The addict is at an increased risk of suicide.

Access your own inner darkness.

Even if you haven’t had the precise experience that you’re describing, you can probably relate, on some level, to aspects. If you were drawn to write dark fiction , in the first place, there’s a reason.

Survivors understand survivors. Research the specifics, but beyond that, write from the heart.

Writing about drug addiction and alcoholism is no easy task, but I hope that these tips will guide and inspire you, as you attempt to realistically portray substance abuse, in your fiction.

More specific information, regarding substance abuse and addiction

Connect with me on social media .

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12 Comments

March 13, 2018 — 3:11 am

This is a great post! I’ve been juggling the idea of writing a fantasy-style work that has some elements of substance abuse in it for a bit, but I have absolutely no experience (personal or otherwise) with the topic, so I’m afraid I won’t be able to do it justice. You listed a ton of things that I never considered, and I’m feeling inspired to go back and try to flesh out the story with more details. Thanks for sharing!

Like Liked by 1 person

March 13, 2018 — 6:41 pm

Thank you, Alex. I really appreciate your positive feedback, and I’m glad I was able to help. It was one of those posts I wrote partly because I struggled myself to find anything like it online. Good luck with your project.

March 14, 2018 — 6:58 am

Thank you for this post! I have a fantasy (epic/high) that revolves around an addiction as one of the primary plot struggles for the MC. While it is not substance or alcohol but rather an animal (yes, the MC is addicted to a beast) they consequences and questions you listed still apply. It brings to light many tips and ideas that I have not yet considered. Very helpful and thank you.

March 14, 2018 — 3:21 pm

Thank you for reading and commenting, Rhia. I’m glad that my post was able to help you. I agree that much of the information can be transferable, and apply to more than drug and alcohol addictions.

June 14, 2018 — 5:26 pm

Wow interesting stuff. Check out myvaliumstory. May give you a new perspective

June 14, 2018 — 6:27 pm

Thank you. And yes, I’ll take a look.

December 12, 2022 — 2:40 am

December 12, 2022 — 9:56 am

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Commonly Used Drugs Charts

Many drugs can alter a person’s thinking and judgment, and can lead to health risks, including addiction, drugged driving, infectious disease, and adverse effects on pregnancy. Information on commonly used drugs with the potential for misuse or addiction can be found here.

On This Page:

For information about treatment options for substance use disorders, see NIDA’s Treatment pages . For drug use trends, see our Trends and Statistics page . For the most up-to-date slang terms, please see  Slang Terms and Code Words: A Reference for Law Enforcement Personnel (DEA, PDF, 1MB) .

For information on alcohol’s health effects, please visit the  National Institute on Alcohol Abuse and Alcoholism  (NIAAA) website.

A tea made in the Amazon from a plant ( Psychotria viridis ) containing the hallucinogen DMT, along with another vine ( Banisteriopsis caapi ) that contains an MAO inhibitor preventing the natural breakdown of DMT in the digestive system, which enhances serotonergic activity. It was used historically in Amazonian religious and healing rituals. For more information, see  Psychedelic and Dissociative Drugs .

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Marijuana is made from the hemp plant, Cannabis sativa . The main psychoactive (mind-altering) chemical in marijuana is delta-9-tetrahydrocannabinol, or THC. For more information, see the Marijuana Research Report .

Medications that slow brain activity, which makes them useful for treating anxiety and sleep problems. For more information, see the Misuse of Prescription Drugs Research Report .

A powerfully addictive stimulant drug made from the leaves of the coca plant native to South America. For more information, see the Cocaine Research Report .

Gamma-hydroxybutyrate (GHB) is a depressant approved for use in the treatment of narcolepsy, a disorder that causes daytime "sleep attacks".

Drugs that cause profound distortions in a person’s perceptions of reality, such as ketamine , LSD , mescaline (peyote) , PCP , psilocybin , salvia , and ayahuasca . For more information, see  Psychedelic and Dissociative Drugs .

An opioid drug made from morphine, a natural substance extracted from the seed pod of various opium poppy plants. For more information, see the Heroin Research Report .

Solvents, aerosols, and gases found in household products such as spray paints, markers, glues, and cleaning fluids; also prescription nitrites.  For more information, see the Inhalants Research Report .

A dissociative drug used as an anesthetic in veterinary practice. Dissociative drugs are hallucinogens that cause the user to feel detached from reality. For more information, see  Psychedelic and Dissociative Drugs .

Pronounced "cot," a shrub ( Catha edulis ) found in East Africa and southern Arabia; contains the psychoactive chemicals cathinone and cathine. People from African and Arabian regions (up to an estimated 20 million worldwide) have used khat for centuries as part of cultural tradition and for its stimulant-like effects.

A tropical deciduous tree ( Mitragyna speciosa ) native to Southeast Asia, with leaves that contain many compounds, including mitragynine, a psychotropic (mind-altering) opioid. Kratom is consumed for mood-lifting effects and pain relief and as an aphrodisiac. For more information, see the Kratom DrugFacts .

A hallucinogen manufactured from lysergic acid, which is found in ergot, a fungus that grows on rye and other grains. LSD is an abbreviation of the scientific name lysergic acid diethylamide . For more information, see Psychedelic and Dissociative Drugs .

A synthetic, psychoactive drug that has similarities to both the stimulant amphetamine and the hallucinogen mescaline. MDMA is an abbreviation of the scientific name 3,4-methylenedioxy-methamphetamine. For more information, see the MDMA (Ecstasy) Research Topic .

A hallucinogen found in disk-shaped “buttons” in the crown of several cacti, including peyote. For more information, see Psychedelic and Dissociative Drugs .

An extremely addictive stimulant amphetamine drug. For more information, see the Methamphetamine Research Report .

Psychoactive when taken in higher-than-recommended amounts. For more information, see the Over the Counter Medicines DrugFacts .

An anti-diarrheal that can cause euphoria when taken in higher-than-recommended doses. For more information, see the Over the Counter Medicines DrugFacts .

A dissociative drug developed as an intravenous anesthetic that has been discontinued due to serious adverse effects. Dissociative drugs are hallucinogens that cause the user to feel detached from reality. PCP is an abbreviation of the scientific name, phencyclidine. For more information, see Psychedelic and Dissociative Drugs .

Pain relievers with an origin similar to that of heroin. Opioids can cause euphoria and are often used nonmedically, leading to overdose deaths. For more information, see the Misuse of Prescription Drugs Research Report .

Prescription cough medicines that contain promethazine (an antihistamine) and codeine are sometimes combined with soda and candy in a drink called “lean” or “sizzurp.”

Medications that increase alertness, attention, energy, blood pressure, heart rate, and breathing rate. For more information, see the Misuse of Prescription Drugs Research Report .

A hallucinogen in certain types of mushrooms that grow in parts of South America, Mexico, and the United States. For more information, see Psychedelic and Dissociative Drugs .

A benzodiazepine chemically similar to prescription sedatives such as Valium® and Xanax® that may be misused for its psychotropic effects. Rohypnol has been used to commit sexual assaults because of its strong sedation effects. In these cases, offenders may dissolve the drug in a person’s drink without their knowledge.

A dissociative drug ( Salvia divinorum ) that is an herb in the mint family native to southern Mexico . Dissociative drugs are hallucinogens that cause the user to feel detached from reality. For more information, see Psychedelic and Dissociative Drugs .

Man-made substances used to treat conditions caused by low levels of steroid hormones in the body and misused to enhance athletic and sexual performance and physical appearance. For more information, see  Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) .

A wide variety of herbal mixtures containing man-made cannabinoid chemicals related to THC in marijuana but often much stronger and more dangerous. Sometimes misleadingly called “synthetic marijuana” and marketed as a “natural,” "safe," legal alternative to marijuana. For more information, see the Synthetic Cannabinoids  DrugFacts .

An emerging family of drugs containing one or more synthetic chemicals related to cathinone, a stimulant found naturally in the khat plant. Examples of such chemicals include mephedrone, methylone, and 3,4-methylenedioxypyrovalerone (MDPV). For more information, see  Synthetic Cathinones

Tobacco is a plant grown for its leaves, which are dried and fermented before use. Tobacco contains nicotine, an addictive chemical. Nicotine is sometimes extracted from the plant and is used in vaping devices. For more information, see the Tobacco, Nicotine and E-Cigarettes Research Report .

United Nations

Office on drugs and crime, press release, unodc world drug report 2024: harms of world drug problem continue to mount amid expansions in drug use and markets, vienna, 26 june 2024.

The emergence of new synthetic opioids and a record supply and demand of other drugs has compounded the impacts of the world drug problem, leading to a rise in drug use disorders and environmental harms, according to the World Drug Report 2024 launched by the UN Office on Drugs and Crime (UNODC) today.

“Drug production, trafficking, and use continue to exacerbate instability and inequality, while causing untold harm to people’s health, safety and well-being,” said Ghada Waly, Executive Director of UNODC. “We need to provide evidence-based treatment and support to all people affected by drug use, while targeting the illicit drug market and investing much more in prevention.”

The number of people who use drugs has risen to 292 million in 2022, a 20 per cent increase over 10 years. Cannabis remains the most widely used drug worldwide (228 million users), followed by opioids (60 million users), amphetamines (30 million users), cocaine (23 million users), and ecstasy (20 million users).

Nitazenes – a group of synthetic opioids which can be even more potent than fentanyl – have recently emerged in several high-income countries, resulting in an increase in overdose deaths.  

Though an estimated 64 million people worldwide suffer from drug use disorders, only one in 11 is in treatment. Women receive less access to treatment than men, with only one in 18 women with drug use disorders in treatment versus one in seven men.

In 2022, an estimated 7 million people were in formal contact with the police (arrests, cautions, warnings) for drug offences, with about two-thirds of this total due to drug use or possession for use. In addition, 2.7 million people were prosecuted for drug offences and over 1.6 million were convicted globally in 2022, though there are significant differences across regions regarding the criminal justice response to drug offences.

The Report includes special chapters on the impact of the opium ban in Afghanistan; synthetic drugs and gender; the impacts of cannabis legalization and the psychedelic “renaissance”; the right to health in relation to drug use; and how drug trafficking in the Golden Triangle is linked with other illicit activities and their impacts.

Drug trafficking is empowering organized crime groups

Drug traffickers in the Golden Triangle are diversifying into other illegal economies, notably wildlife trafficking, financial fraud, and illegal resource extraction. Displaced, poor, and migrant communities are suffering the consequences of this instability, sometimes forced to turn to opium farming or illegal resource extraction to survive, falling into debt entrapment with crime groups, or using drugs themselves.

These illicit activities are also contributing to environmental degradation through deforestation, the dumping of toxic waste, and chemical contamination.

Consequences of cocaine surge

A new record high of 2,757 tons of cocaine was produced in 2022, a 20 per cent increase over 2021. Global cultivation of coca bush, meanwhile, rose 12 per cent between 2021 and 2022 to 355,000 hectares. The prolonged surge in cocaine supply and demand has coincided with a rise in violence in states along the supply chain, notably in Ecuador and Caribbean countries, and an increase in health harms in countries of destination, including in Western and Central Europe.

Impact of cannabis legalization

As of January 2024, Canada, Uruguay, and 27 jurisdictions in the United States had legalized the production and sale of cannabis for non-medical use, while a variety of legislative approaches have emerged elsewhere in the world.

In these jurisdictions in the Americas, the process appears to have accelerated harmful use of the drug and led to a diversification in cannabis products, many with high-THC content. Hospitalizations related to cannabis use disorders and the proportion of people with psychiatric disorders and attempted suicide associated with regular cannabis use have increased in Canada and the United States, especially among young adults.

Psychedelic “renaissance” encourages broad access to psychedelics

Though interest in the therapeutic use of psychedelic substances has continued to grow in the treatment of some mental health disorders, clinical research has not yet resulted in any scientific standard guidelines for medical use.

However, within the broader “psychedelic renaissance”, popular movements are contributing to burgeoning commercial interest and to the creation of an enabling environment that encourages broad access to the unsupervised, “quasi-therapeutic” and non-medical use of psychedelics. Such movements have the potential to outpace the scientific therapeutic evidence and the development of guidelines for medical use of psychedelics, potentially compromising public health goals and increasing the health risks associated with the unsupervised use of psychedelics.

Implications of opium ban in Afghanistan

Following the drastic decrease of Afghanistan’s opium production in 2023 (by 95 per cent from 2022) and an increase in production in Myanmar (by 36 per cent), global opium production fell by 74 per cent in 2023. The dramatic contraction of the Afghan opiate market made Afghan farmers poorer and a few traffickers richer. Long-term implications, including on heroin purity, a switch to other opioids by heroin users, and/or a rise in demand for opiate treatment services may soon be felt in countries of transit and destination of Afghan opiates.

Right to health for people who use drugs

The report outlines how the right to health is an internationally recognized human right that belongs to all human beings, regardless of a person’s drug use status or whether a person is imprisoned, detained or incarcerated. It applies equally to people who use drugs, their children and families, and other people in their communities.

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Here’s What the Court’s Chevron Ruling Could Mean in Everyday Terms

The decision is expected to prompt a rush of litigation challenging regulations across the entire federal government, from food safety to the environment.

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By Coral Davenport ,  Christina Jewett ,  Alan Rappeport ,  Margot Sanger-Katz ,  Noam Scheiber and Noah Weiland

• June 28, 2024

The Supreme Court’s decision on Friday to limit the broad regulatory authority of federal agencies could lead to the elimination or weakening of thousands of rules on the environment, health care, worker protection, food and drug safety, telecommunications, the financial sector and more.

The decision is a major victory in a decades-long campaign by conservative activists to shrink the power of the federal government, limiting the reach and authority of what those activists call “the administrative state.”

The court’s opinion could make it easier for opponents of federal regulations to challenge them in court, prompting a rush of new litigation, while also injecting uncertainty into businesses and industries.

“If Americans are worried about their drinking water, their health, their retirement account, discrimination on the job, if they fly on a plane, drive a car, if they go outside and breathe the air — all of these day-to-day activities are run through a massive universe of federal agency regulations,” said Lisa Heinzerling, an expert in administrative law at Georgetown University. “And this decision now means that more of those regulations could be struck down by the courts.”

The decision effectively ends a legal precedent known as “Chevron deference,” after a 1984 Supreme Court ruling. That decision held that when Congress passes a law that lacks specificity, courts must give wide leeway to decisions made by the federal agencies charged with implementing that law. The theory was that scientists, economists and other specialists at the agencies have more expertise than judges in determining regulations and that the executive branch is also more accountable to voters.

Since then, thousands of legal decisions have relied on the Chevron doctrine when challenges have been made to regulations stemming from laws like the 1938 Fair Labor Standards Act, the 1970 Clean Air Act , the 2010 Affordable Care Act and others.

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World Drug Day report highlights spike in drug use, increased trafficking

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The UN agency tackling crime and drug abuse (UNODC) released its annual World Drug Report on Wednesday warning that there are now nearly 300 million users globally, alongside an increase in trafficking.

The  International Day against Drug Abuse and Illicit Trafficking, or World Drug Day, is commemorated every year on June 26 and aims to increase action in achieving a drug-free world.

This year’s campaign recognises that “ effective drug policies must be rooted in science, research, full respect for human rights , compassion, and a deep understanding of the social, economic, and health implications of drug use”.

Ghada Waly, Executive Director of UNODC , said that providing evidence-based treatment and support to all those affected by drug use is needed, “while targeting the illicit drug market and investing much more in prevention”.

New threat from nitazenes

Drug production, trafficking, and use continue to exacerbate instability and inequality, while causing untold harm to people’s health, safety and well-being. — Ghada Waly

In the decade to 2022, the number of people using illicit drugs increased to 292 million, the UNODC report says.

It noted that most users worldwide consume cannabis – 228 million people - while 60 million people worldwide consume opioids, 30 million people use amphetamines, 23 million use cocaine and 20 million take ecstasy.

Further, UNODC found that there was an increase in overdose deaths following the emergence of nitazenes – a group of synthetic opioids potentially more dangerous than fentanyl – in several high-income countries.

Trafficking in the Triangle

The drug report noted that traffickers in the Golden Triangle, a region in Southeast Asia, have found ways to integrate themselves into other illegal markets, such as wildlife trafficking, financial fraud, and illegal resource extraction.

“Displaced, poor and migrant communities” bear the brunt of this criminal activity and on occasion are forced to engage in opium farming or illegal resource extraction for their survival; this can lead to civilians becoming drug users or fall into debt at the mercy of crime groups.

Environmental fallout

These illegal crimes contribute to environmental degradation via deforestation, toxic waste dumping and chemical contamination.

“Drug production, trafficking, and use continue to exacerbate instability and inequality, while causing untold harm to people’s health, safety and well-being,” UNODC’s Ms. Waly said.

Cocaine surge and cannabis legalisation

In 2022, cocaine production hit a record high with 2,757 tons produced – a 20 per cent increase from 2021.

The increase in supply and demand of the product was accompanied by a surge of violence in nations along the supply chain, especially in Ecuador and Caribbean countries. There was also a spike in health problems within some destination countries in Western and Central Europe.

Similarly, harmful usage of cannabis surged as the product was legalized across Canada, Uruguay, and 27 jurisdictions in the United States, much of which was laced with high-THC (delta9-tetrahydrocannabinol) content - which is believed to be the main ingredient behind the psychoactive effect of the drug.

This led to an increase in the rate of attempted suicides among regular cannabis users in Canada and the US.

The hope for World Drug Day

The UNODC report highlights that the “ right to health is an internationally recognized human right that belongs to all human beings , regardless of a person’s drug use status or whether a person is imprisoned, detained or incarcerated”.

UNODC’s calls for governments, organizations and communities to collaborate on establishing evidence-based plans that will fight against drug trafficking and organized crime.

The agency also hopes communities will assist in “fostering resilience against drug use and promoting community-led solutions".